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§ 884.1425 Perineometer.

21 CFR 884.1425

Citation21 CFR 884.1425
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 884.1425 Perineometer.

(a) Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

(b) Classification. Class II (performance standards).